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Collegiate, Alumnae Members Unite In Memphis To Recognize Raising More Than $68 Million For The Hospital

MEMPHIS, Tenn., June 28, 2019 /PRNewswire/ — This year marks 20 years of partnership between Tri Delta and St. Jude Children’s Research Hospital®, which is leading the way the world understands, treats and defeats childhood cancer and other life-threatening diseases.

Since Tri Delta first adopted St. Jude as its national philanthropic partner in 1999, the organization has raised more than $68 million to support the hospital’s mission: Finding cures. Saving children.® Partnerships like this help ensure families never receive a bill from St. Jude for treatment, travel, housing or food – because all a family should worry about is helping their child live.

“After two decades of partnership with Tri Delta, I still find myself astonished by the lasting effect these inspiring women have made on the St. Jude campus and in the lives of our patient families,” said Richard Shadyac Jr., President and CEO of ALSAC, the fundraising and awareness organization for St. Jude Children’s Research Hospital. “Perhaps more impressive than the organization’s exceptional impact is the indelible impression of St. Jude each of its members leaves on their peers and communities as they rally support across the nation.”

Today through Sunday, June 30, more than 400 Tri Delta alumnae and collegiate members from across North America will gather on the hospital’s campus in Memphis, Tennessee, for its annual St. Jude Tri Delta Celebration. During this special leadership weekend, attendees will hear from hospital staff and patient families, tour the hospital and celebrate collegiate leaders who fundraise tirelessly for the kids of St. Jude.

“As an organization founded to be kind alike to all, there is no greater example of Tri Delta’s kindness than our work with St. Jude. We are honored to help promote their groundbreaking research and support their effort to change the futures of so many children facing cancer,” said Tri Delta CEO Karen Hughes.

In 2014, Tri Delta committed to raising $60 million in 10 years for St. Jude, which is the single largest commitment by a St. Jude partner since the hospital opened more than 50 years ago. In honor of this momentous pledge, the hospital recognized Tri Delta on the St. Jude campus with the naming of its short-term housing facility, Tri Delta Place. The organization has already met more than half of this commitment in just five years, with $41 million raised toward the $60 million pledge.

Tri Delta members’ passion to raise funds and awareness for St. Jude is regularly displayed nationwide through programs like its Sincerely Yours letter-writing campaign, participation in the St. Jude Walk/Run, involvement in local galas and much more.

About St. Jude Children’s Research Hospital®St. Jude Children’s Research Hospital is leading the way the world understands, treats and defeats childhood cancer and other life-threatening diseases. Its purpose is clear: Finding cures. Saving children.® It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments invented at St. Jude have helped push the overall childhood cancer survival rate from 20 percent to more than 80 percent since the hospital opened more than 50 years ago. St. Jude won’t stop until no child dies from cancer. St. Jude freely shares the discoveries it makes, and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing or food – because all a family should worry about is helping their child live. Join the St. Jude mission by visiting stjude.org, sharing stories and videos from St. Jude Inspire, liking St. Jude on Facebook, following St. Jude on Twitter and Instagram and subscribing to its YouTube channel.

About Tri DeltaFounded in 1888, Tri Delta is a premier women’s organization dedicated to helping women live, learn and lead – with Purpose – for a lifetime. With more than 237,000 members worldwide, Tri Delta operates 141 collegiate chapters and 58 chapter facilities on campuses across North America., and provides resources and support to 62 local house corporations and 245 alumnae chapters globally. As a society created to be “kind alike to all,” Tri Delta is rooted in kindness with three aspects of philanthropic focus: sisters helping sisters through the Tri Delta Foundation and support for childhood cancer at the local/regional level and nationally through its 20-year partnership with St. Jude Children’s Research Hospital.

HealthTech Arkansas, Arkansas Heart Hospital, the University of Arkansas for Medical Sciences (UAMS), Washington Regional Medical Center, Arkansas Urology, Mercy, and CHI St. Vincent today announced they are collaborating to extend and expand HealthTech Arkansas, a program that connects early-stage healthcare companies bringing disruptive technologies to the marketplace with Arkansas healthcare providers for the purpose of conducting pilot projects.

HealthTech Arkansas is a new and expanded iteration of two previous accelerator programs, Health InnovatAR and HubX—LifeSciences. This year, with more provider partners and increased investment for participating companies, HealthTech Arkansas is increasingly focused on bringing the most innovative healthcare technologies to Arkansas. HealthTech Arkansas will be directed by Jeff Stinson, who has managed the previous two healthcare accelerators in Arkansas. Stinson is also the executive director of the Fund for Arkansas’ Future, which is the state’s largest angel investment fund.

“The guaranteed opportunity to conduct pilot projects with healthcare providers is what truly sets our program apart from other accelerators,” said Stinson. “Provider access for early stage companies is the most important thing you can do for their success. Through these pilot projects, our cohort companies get a direct connection to hospitals and physicians that give them the opportunity to demonstrate value with their technologies and products.”

The impact on healthcare providers is also beneficial. “UAMS has a mission to educate tomorrow’s healthcare professionals and provide high-quality, innovative care,” said Dr. Richard Turnage, CEO of UAMS Medical Center. “We are excited to continue our partnership with HealthTech Arkansas, giving our patients access to new, innovative technologies, and inspiring our employees to be more innovative every day.”

The Arkansas Economic Development Commission awarded HealthTech Arkansas $250,000 for the healthcare accelerator through a program designed to increase acceleration activities in targeted industries in the state.

“Our culture is built upon embracing new technologies that help us provide better patient care,” said Andrea Nelson, Chief Clinical Officer at Arkansas Heart Hospital. “We’ve found HealthTech Arkansas to be a highly impactful way for us to identify early-stage companies with new healthcare technologies and engage with them in a way that delivers significant value to both our hospital and the companies.”

Applications for the HealthTech Arkansas cohort are now open, and the cohort will be selected by June 30, 2019. The program is seeking companies in three categories: digital health and software, connected medical devices, and diagnostic platforms. Each company will receive $75,000 of investment capital and is guaranteed two pilot projects with Arkansas healthcare providers.

More information about HealthTech Arkansas, including an online application, can be found at HealthTechArkansas.com.

Dynamic Health IT Executive From DXC Technology, IBM, And Surescripts Named Chief Operating Officer Of Akiri

Healthcare interoperability startup Akiri™ today announced the appointment of Chief Operating Officer Jeff Miller, a corporate technology leader and expert in health data liquidity. Miller has devoted his career to health and technology initiatives for Hewlett-Packard Enterprise, IBM, and health tech company Surescripts, among others. Miller will work alongside healthcare visionaries that hail from from Cisco, Kaiser Permanente, and Oracle to build a universal platform for data exchange designed to meet the needs of the complex U.S. healthcare ecosystem.

Akiri is the first company spun out of Health2047 Inc., the Silicon Valley-based business formation and commercialization enterprise whose founding investor and primary strategic partner is the American Medical Association (AMA). Miller brings to Akiri his broad experience working with healthcare providers, payers, and life sciences enterprises to unlock the value of health data. Over the past 25 years, Miller has held a diverse set of executive positions. He served as CEO of the North Carolina Health Information Exchange (NCHIE), a nonprofit that created a secure technology service to support real-time exchange, utilization, and analysis of health information. Additionally, Miller has held healthcare industry-focused executive roles at Deloitte Consulting, DXC Technology (formerly CSC), Hewlett-Packard, IBM, and Surescripts.

“Jeff has paved the way for pioneering companies in healthcare and IT environments, identifying innovative ways to leverage data along the way,” said David Watson, CEO, Akiri. “His expertise will shape the future of our product and undoubtedly enhance Akiri’s efforts to simplify the exchange of clinical and administrative data to enable far greater data liquidity across our health care system.”

Since its public launch earlier this year, Akiri has been building a trusted network that enables any type of health information to be permissioned and move seamlessly and securely throughout the U.S. healthcare system in accordance with those permissions. The startup has already filed multiple patent applications for its proprietary networking technology. With a focus on supporting drug safety programs and clinical trials as its first application areas, Akiri is also currently collaborating with a major global pharmaceutical company to share clinical data between physicians, patients, and hospitals.

“Healthcare as an industry needs solutions that enhance cross-enterprise interoperability and enable data to flow more effectively and spark innovation,” said Jeff Miller, COO, Akiri. “My career has taught me that while there is no shortage of healthcare data, it’s typically stuck in organizational silos, where its value is greatly diminished. I am honored to join Akiri’s mission to improve data liquidity and ensure the right data can get to the right person at the right time to create better healthcare outcomes.”

About AkiriAkiri Inc. provides the trusted interoperability platform for the healthcare ecosystem. Akiri is dedicated to helping patients, physicians, providers, pharma, and other healthcare enterprises travel safely on their digital journeys. For more information, visit https://akiri.com.

About Health2047 Inc.Health2047 Inc. is a Silicon Valley business formation and commercialization enterprise committed to catalyzing fundamental transformation in U.S. healthcare. The company’s specific areas of focus include data liquidity, chronic care management, radical productivity enhancement, and value-based payment. Health2047’s deep relationships with both the American Medical Association and its network of strategic partners create a unique force multiplier that helps drive large-scale changes in healthcare. For more information, please visit https://health2047.com.

CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of joint surface lesions, announced today the publication of a study demonstrating that the Agili-C™ implant promotes the regenerative capacity of articular cartilage defects in human cadaveric ex-vivo model. The study, published in KSSTA Journal – Knee Surgery, Sports Traumatology, Arthroscopy (01 November 2018, PP 1-12), was conducted at Rush University in Chicago by Prof. Susan Chubinskaya.

The goal of the study was to investigate the ex-vivo Mechanism Of Action of the Agili-C™ implant in the repair of full-thickness cartilage defects. In particular, it was intended to validate whether the Agili-C™ implant has the potential to stimulate cartilage in-growth through chondrocyte migration into the 3D interconnected porous structure of the scaffold, along with maintaining their viability and phenotype and the deposition of hyaline cartilage matrix.

In the study, human articular cartilage cadaveric knee and ankle specimens were collected within 24 hours from death from 14 donors, male and female. To model a chondral defect, donut-shaped cartilage explants were prepared from each tissue specimen. Cartilage explants with or without the Agili-C™ implant inside were cultured for 60 days.

The results of the study confirmed the ability of chondrocytes to migrate outside of the cadaveric cartilage explant tissue and into the porous structure of the Agili-C™ scaffold and fill its entire volume with newly formed extracellular matrix (ECM) enriched in hyaline cartilage components, such as collagen type II and aggrecan, and lacking collagen type I.

In addition, the study demonstrated the formation of a layer populated by progenitor-like cells on the articular surface of the implant. These cells were able to produce a thin layer that covered the surface of the newly formed extracellular matrix, similar to a lamina.

In the absence of a scaffold, chondrocytes did not migrate far from the tissue with probably some degree of hypertrophy.

In conclusion, the analysis of samples taken from knee and ankle joints of human donors confirmed that the Agili-C™ implant induces deposition of new extracellular matrix with similar characteristics to the native hyaline cartilage inside the entire volume of the scaffold.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE study.

Flex (NASDAQ: FLEX), the Sketch-to-Scale® solutions provider that designs and builds Intelligent Products for a Connected World®, today announced a partnership with Novo Nordisk to develop digital health solutions for diabetes patients. After rigorous evaluation, Novo Nordisk selected the medical-grade BrightInsight™ platform from Flex Digital Health to build and operate these solutions and securely manage millions of its smart medical devices and the corresponding data within a regulatory-compliant environment.

BrightInsight provides a unified IoT platform that enables organizations to develop and host digital health devices, apps and algorithms at scale while maintaining compliance with privacy, security and regulatory requirements across the globe. Compared to building a custom platform from scratch, BrightInsight’s robust functionality facilitates lower costs and accelerates time to market.

“Traditional methods of managing diabetes have not kept pace with a world moving at digital speed,” said Kal Patel, M.D. and SVP of Digital Health at Flex. “BrightInsight securely unlocks real-world data and actionable insights, enabling pharma and medtech companies to develop advanced, regulated digital health solutions that enable automated clinical decisions and better engagement between clinicians and people with diabetes.”

By collaborating with Flex and utilizing Flex’s established platform, BrightInsight, Novo Nordisk can focus on developing innovative medicines with the goal of improving patient outcomes.

“Addressing the growing diabetes epidemic takes more than best-in-class medicines alone. We need to engage with people on their level and integrate with the solutions they are already using to manage their diabetes,” said Anders Dyhr Toft, corporate vice president of Commercial Innovation at Novo Nordisk. “Medical-grade digital health platforms like BrightInsight are key to helping us improve the dialogue between people with diabetes and their caregivers.”

BrightInsight is an advanced, medical-grade managed service platform that can capture and analyze data from connected medical devices, combination products, apps or Software as a Medical Device (SaMD) in a secure, regulatory-compliant environment. BrightInsight’s Device Master File has been accepted by the FDA and Flex Digital Health is ISO 13485:2016 certified.

This announcement further builds on Flex’s current Sketch-to-Scale engagement to help design and manufacture elements of Novo Nordisk’s new connected insulin pens. The new partnership with Novo Nordisk follows another recent milestone for Flex Digital Health, the inauguration of the BrightInsight Clinical Board, which was established to incorporate physician insight and workflow experience in the development of digital health tools. In addition, Flex Digital Health and the Boston Consulting Group recently published a white paper titled, “The Evolving Role of the Biopharma and Medtech CIO: How to Succeed in Today’s Digital Era.”

About Flex
Flex is the Sketch-to-Scale® solutions provider that designs and builds Intelligent Products for a Connected World®. With approximately 200,000 professionals across 30 countries, Flex provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information, visit flex.com or follow us on Twitter @flexintl. Flex – Live Smarter®

Flex (NASDAQ :FLEX ), the Sketch-to-Scale® solutions provider that designs and builds Intelligent Products for a Connected World®, has assembled a clinical advisory board to leverage the perspectives of leading doctors for the development of powerful digital health solutions that integrate into and improve clinical workflow to make a real-world impact on patient outcomes. Going beyond consumer-grade digital health, Flex’s Digital Health business and the BrightInsight™ Clinical Board will be focused on advancing medical-grade digital health solutions that effectively integrate into providers’ clinical workflow with the goal of improving patient outcomes.

“As we continue to develop leading-edge digital health solutions, it’s paramount that we keep clinical workflow and the clinician’s point-of-view top of mind,” said Kal Patel, M.D. and SVP of Digital Health at Flex. “Although we are seeing a proliferation of effective digital health solutions coming to market, they almost universally lack integration into the health care professional’s clinical workflow. Without this integration, these solutions will not be able to achieve scale and deliver upon their promise to make a clinical and economic impact at the population level. We are honored to be working with leading clinicians to help us tackle these challenges.”

The BrightInsight Clinical Board will advise Flex’s Digital Health business – from concept to commercialization – to ensure advancements in three core areas: clinical workflow integration, designing solutions that engage patients in self-care, and facilitating the capture of clinically-relevant data and analytics.

The members of the advisory board include:

Steven Edelman, M.D. – Dr. Steven Edelman is a professor of medicine in the Division of Endocrinology, Diabetes & Metabolism at the University of California at San Diego and the Veterans Affairs Healthcare System of San Diego, and the director of the Diabetes Care Clinic, VA Medical Center. Dr. Edelman is very interested in patient advocacy and is the founder and director of Taking Control of Your Diabetes, a not for profit organization with the goal of educating, motivating and empowering those affected by diabetes to take a more active role in their or their loved one’s condition.

Tania Elliott, M.D., FAAAAI, FACAAI – Dr. Tania Elliott is on faculty at NYU Langone Health and is a national spokesperson for the American College of Allergy, Asthma, and Immunology. Dr. Elliott is a nationally-recognized leader in telemedicine, serving as first author for a position paper on telemedicine for Allergists and having previously worked for Doctor on Demand where she saw thousands of patients through real-time face-to-face video consultations while recruiting and training top physicians around the country. She previously served as the Chief Medical Officer of the employer based healthcare company, EHE, where she focused on patient engagement, preventive care and digital transformation.

Arturo Loaiza-Bonilla, M.D., MSEd, FACP – Dr. Arturo Loaiza-Bonilla is the current Vice Chairman of the Department of Medical Oncology at Cancer Treatment Centers of America, Chief of Medical Oncology and Medical Director of Research at CTCA – Philadelphia, and Co-Founder and Chief Medical Officer at Massive Bio. Dr. Loaiza-Bonilla is a dedicated practicing clinician and oncology expert with experience at Abramson Cancer Center at the University of Pennsylvania, University of Miami, Johns Hopkins and the National Institutes of Health.

Steven Steinhubl, M.D. – Dr. Steven Steinhubl is an Associate Professor of Genomic Medicine at Scripps Research, a clinical cardiologist and the Director of Digital Medicine at the Scripps Research Translational Institute. As the head of the Digital Medicine Division of STSI, he leads a research team in the design, development and management of clinical programs built specifically around the novel capabilities of digital technologies, including wearable sensors and big data analytics.

Flex launched BrightInsight, its first digital health offering, in March 2018. The announcement marked an expansion of Flex’s digital health capabilities through the company’s ability to offer an advanced, medical-grade managed service platform that can capture and analyze regulated data from connected medical devices, combination products or apps in a secure, regulatory-compliant environment.

About Flex
Flex is the Sketch-to-Scale® solutions provider that designs and builds Intelligent Products for a Connected World®. With approximately 200,000 professionals across 30 countries, Flex provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information, visit flex.com or follow us on Twitter @flexintl. Flex – Live Smarter®

Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced that members of the leadership team will present at the following upcoming investor conferences in New York City:

The live audio webcasts from the conferences and subsequent replay may be accessed by visiting the “Events & Presentations” page in the investors section of Tocagen’s website. The webcasts will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

About Tocagen Inc.Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. Tocagen’s lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.

INDIANAPOLIS, Sept. 27, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults.1 Emgality offers a once-monthly, self-administered, subcutaneous injection.1 Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.1

Emgality will be available to patients shortly after approval. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly’s patient support program (governmental beneficiaries excluded; subject to terms and conditions*). Emgality will be available for pickup at retail pharmacies.

Migraine is a disabling, neurologic disease that affects more than 30 million American adults.2,3,4,5,6 According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually, yet migraine remains under-recognized and under-treated.4,7,8

“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” said Christi Shaw, president, Lilly Bio-Medicines. “For more than two decades, Lilly has recognized this unmet need, and we have worked tirelessly to develop a new option specifically designed for the prevention of migraine. With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”

The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1 and EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN).

EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month). REGAIN was a three-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.

• Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001)
• At least a 50 percent reduction in MHDs in any given month on average (% responders): 62% (N=210) for Emgality 120 mg compared to 39% (N=425) for placebo (p<0.001)
• At least a 75 percent reduction in MHDs in any given month on average (% responders): 39% (N=210) for Emgality 120 mg compared to 19% (N=425) for placebo (p<0.001)
• 100 percent reduction in MHDs in any given month on average (% responders): 16% (N=210) for Emgality 120 mg compared to 6% (N=425) for placebo (p<0.001)
EVOLVE-2 (Over Months 1 to 6 – baseline migraine headache days: Emgality 9.1, placebo 9.2)1,9
• Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001)
• At least a 50 percent reduction in MHDs in any given month on average (% responders): 59% (N=226) for Emgality 120 mg compared to 36% (N=450) for placebo (p<0.001)
• At least a 75 percent reduction in MHDs in any given month on average (% responders): 34% (N=226) for Emgality 120 mg compared to 18% (N=450) for placebo (p<0.001)
• 100 percent reduction in MHDs in any given month on average (% responders): 12% (N=226) for Emgality 120 mg compared to 6% (N=450) for placebo (p<0.001)
REGAIN (Over Months 1 to 3 – baseline migraine headache days: Emgality 19.4, placebo 19.6)1,9
• Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001)
• At least a 50 percent reduction in MHDs in any given month on average (% responders): 28% (N=273) for Emgality 120 mg compared to 15% (N=538) for placebo (p<0.001)

• Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the three-month treatment period.

The recommended dose for Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously.1

The safety of Emgality was evaluated in three clinical trials that included more than 2,500 patients.1,9 Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies, can occur days after administration and may be prolonged. The most common adverse reactions (incidence ≥2% for Emgality and at least 2% greater than placebo) associated with Emgality treatment (120 mg vs. placebo) were injection site reactions (18% vs. 13%). See additional Important Safety Information below.

The U.S. list price of Emgality is $575 once-monthly, or $6,900 annually.

“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible,” said Shaw. “Lilly’s choice to provide Emgality for up to 12 months free to all eligible patients with commercial insurance* underscores our 25-year commitment to recognizing and addressing the need experienced by those with migraine.”

Patients and healthcare professionals with questions about Emgality should contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or 1-833-EMGALITY or visit www.lilly.com. Patients can also text INFO to 54559 to receive an injection how-to video and other helpful resources delivered straight to their phone.

“I have lived with migraine for more than 30 years, and I have experienced firsthand the impact it has on your life, including the ability to perform daily activities,” said Jill Dehlin, chair, Patient Leadership Council, National Headache Foundation. “Those of us living with migraine have spent years hoping for new treatment options, and I am thankful for the efforts by researchers, investigators and clinical trial patients who have helped make this possible.”

On September 21, 2018, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Emgality for the prophylaxis of migraine in adults who have at least four migraine days per month. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union.

Indications and Usage

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.
Important Safety Information

Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Warnings and Precautions
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.
Adverse Reactions

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the pen and prefilled syringe.

GZ HCP ISI 27SEP2018

*Terms and Conditions:
Offer good for up to 12 months until 12/31/2020 if healthcare provider submits the prior authorization form or letter of medical necessity, if required, to the patient’s insurance provider. $0 monthly offer for commercially insured with insurance provider coverage, subject to wholesale acquisition cost plus usual and customary pharmacy charges and a separate $4900 maximum annual cap. $0 monthly offer for commercially insured without insurance provider coverage, subject to monthly and annual cap of wholesale acquisition cost plus usual and customary pharmacy charges.

*By using the Emgality Savings Card (“Card”), you attest that you meet the eligibility criteria and will comply with the Terms and Conditions described below:
• Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any state patient or pharmaceutical assistance program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (12/31/2020); (ii) the date an AB-rated generic equivalent for Emgality becomes available; or (iii) June 30, 2019, absent a change in Massachusetts state law. If you live in California, the Card expires on the earlier of: (i) the expiration date of this Card (12/31/2020) or (ii) the date an FDA-approved therapeutically equivalent for Emgality or over-the-counter product with the same active ingredients becomes available.
Available only in the US and Puerto Rico for residents of the US and Puerto Rico. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving Emgality. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade; or to counterfeit this Card. This offer may be terminated, rescinded, revoked, or amended by Lilly USA, LLC, at any timewithout notice. This Card is not health insurance. This Card expires on 12/31/2020.

About the EVOLVE-1 and EVOLVE-2 Studies1

EVOLVE-1 and EVOLVE-2 were six-month, double-blind, placebo-controlled studies that enrolled a total of 1773 adult patients with episodic migraine (defined as 4-14 migraine headache days per month). Participants were randomized to once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The studies excluded patients on any other migraine preventive treatment, patients with medication overuse headache, patients with electrocardiogram abnormalities compatible with an acute cardiovascular event and patients with a history of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. For each study, the primary endpoint was the mean change from baseline in the number of monthly MHDs over Months 1 to 6 in the intent-to-treat study population. Emgality is approved as a 120 mg injection. Emgality 240 mg is not an approved dose.

About the REGAIN Study1

REGAIN was a 3-month, double-blind, placebo-controlled study that enrolled 1113 adult patients with chronic migraine (defined as ≥15 headache days per month with ≥8 migraine days per month). Participants were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. A subset of patients (15%) continued one concomitant migraine preventive medication. Patients were excluded if they had electrocardiogram abnormalities compatible with an acute cardiovascular event and patients with a history of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the 3-month treatment period. Emgality is approved as a 120 mg injection. Emgality 240 mg is not an approved dose.

About Migraine

Migraine is a disabling, neurologic disease characterized by recurrent episodes of severe headache accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision.2,3 More than 30 million American adults have migraine, with three times more women affected by migraine compared to men.4,5,6,10 According to the Medical Expenditures Panel Survey, the total unadjusted cost associated with migraine in the U.S. is estimated to be as high as $56 billion annually, yet migraine remains under-recognized and under-treated.4,7,8

About Emgality

Emgality is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and blocks its binding to the receptor. Emgality offers a once-monthly, self-administered, subcutaneous injection.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.

P-LLY

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Bgogo Exchange, a new name to the digital asset exchange world, officially listed BGG/ETH and BGG/BTC trading pairs on September 16, 2018.

During Genesis Mining, where BGG was offered to the most loyal and supportive users at an unprecedented price cheaper than private sale investors, BGG underwent a heated and volatile stage followed by a leveled and steady progression. Currently, BGG has maintained a value three times the price of Genesis Mining.

On the first trading day, the total volume for the exchange surpassed $420 million USD. This is a noteworthy outcome considering the current market conditions overall.

What’s the Secret of BGG’s Success?

BGG has broken all the rules and conventions for initial coin offerings (ICOs). Bgogo’s mantra is the cryptocurrency exchange of the community, by the community for the community. Bgogo is paving the path to offer for common investors more to gain than the typical short-sighted beneficiaries such as project owners, institutional investors, and exchanges.

With its unusual yet captivating launch, BGG has set an example in the current standstill the cryptocurrency industry is in by redefining the concept of an ICO.

What’s Wrong with the Current ICO Model

ICOs offer investors an opportunity to profit by granting them exclusive access to blockchain projects at an early stage prior to the project’s debut.

ICOs should reflect the spirit of the blockchain community through a democratic, transparent and holistic culture.

However, the current and common ICO model has deviated from the practices blockchain enables and drifted into a world of scams and corruption. Some of these so-called “projects”, “exchanges” and “token funds” have taken advantage of current trends and utilize their resources to mislead and siphon money from common investors.

Currently, exchanges and pre-sale based institutions have the ability to secure stakes at lower prices. It is a given that project issuers possess a majority of their own tokens. The options available for the common investor are limited to the point where common investors are left to the will of institutional investors.

The industry will simply reflect what is being produced. If the current state of ICOs and trust in projects does not change, the industry will be buried.

BGG Abandons Traditional ICO Model

For the first time in the industry, the BGG positions of supernodes are published and updated regularly on Bgogo’s official website for the public. With this level of transparency, Bgogo aims to set an example to combat the current imbalance that is plaguing the industry.

Upon listing BGG on its platform, the 21 reputable institutions that make up the supernodes were granted access to their holdings. Thus far, most of the supernodes have held their allocations, refraining from selling them in the secondary market. Reputable institutions such as Sky9 Capital, IMO Ventures, Utopia Capital, Dfund and ICO Drops have actually increased their BGG positions.

DKB Fund, who previously decreased their holdings, lowering their supernode rank, rebought more than 7 million BGG tokens.

Institutional investors that choose to decrease their BGG positions within the first two months are not valued investors. It’s impossible for a project to create value in such a short time.

Institutional investors that conduct due diligence on their investments targets and can accept holding long-term, can truly experience the benefits from legitimate visionary projects. Institutions that adopt this outlook for projects would set a great example for common investors, otherwise what is the difference between an institutional investor and a common investor?

During Genesis Mining, which took place on September 15, 2018, more than 1,000 Bgogo community members were allocated an equivalent of 2,250 ETH at a price lower than what was offered to institutional investors. This completely broke all the conventions for the traditional ICO model which favors institutional investors by offering them a lower pre-sale price. Bgogo decided to rewrite the rules and offer an even better deal to the common investors.

Many users were able to participate in Genesis Mining. They were selected through a Bgogo “Proof of Care” (POC) contest where contestants showed their support through sharing and generating original content on social media. Bgogo received over 50,000 submissions representing 55 different countries, of which 1,000 outstanding entries were chosen and ranked. The POC contest did not only help build momentum for the launch of the BGG, but it cultivated a supportive diverse community.

Token Issuance as a Financing Tool in the Traditional Model

In traditional ICO models, tokens are often issued through fund-raising. Regardless of the financial status of a project, owners raise funds for the mere fact of just raising funds, among other questionable reasons. Fund-raising usually generates thousands of Ethereum, the most commonly accepted for funding blockchain projects.

EOS, a well-known project, raised about 7 million ETH within 350 days, an equivalent to $4.2 billion USD today. There are thousands of other projects similar to EOS, all to say that their intentions are typically hidden behind crypto and blockchain jargon in endless white papers and can simply run away with the funds raised.

Token Issuance as a Tool for User Growth

The Bgogo teams believe that the BGG token serves as the most important mechanism for user growth rather than fund-raising. To show this, Bgogo has adopted a practical outlook for financing its projects. Bgogo’s strict limits for the collective supernode allocations (15,000 ETH), which are subject to lock-up periods of up to 5 months, benefited Genesis Mining participants with a price lower than institutional investors with no lock-up period.

Within the first 24 hours of BGG trading pairs going live, exclusively on the Bgogo exchange, the trading volume surpassed $420 million USD with over 5,000 users online simultaneously. This traffic and liquidity are comparable to other in-house projects by industry giants. BGG has also reached stability at three times its Genesis Mining value. Community leaders have even volunteered to maintain and improve the spirit of Bgogo as it continues to grow.

Unique to the cryptocurrency exchange community, Bgogo’s implementation of trade mining has performed very well as reflected by BGG’s steady growth rate. A user from the community recently said, “Just like Google or Amazon stock, buying BGG at any time during the current stage is the right thing to do for the long term.” The BGG price will reflect the consistent growth in user base, increased trading volume, and the addition of high-quality assets.